Cleared Special

Ureterorenoscope System

K201293 · Shanghai AnQing Medical Instrument Co., Ltd. · Gastroenterology & Urology
Jul 2020
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K201293 is an FDA 510(k) clearance for the Ureterorenoscope System, a Ureteroscope And Accessories, Flexible/rigid (Class II — Special Controls, product code FGB), submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 24, 2020, 71 days after receiving the submission on May 14, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K201293 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2020
Decision Date July 24, 2020
Days to Decision 71 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGB — Ureteroscope And Accessories, Flexible/rigid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Perform Various Diagnostic And Therapeutic Procedures Within The Urinary Tract. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).

Similar Devices — FGB Ureteroscope And Accessories, Flexible/rigid

All 111
CVAC Image Processor
K260013 · Calyxo, Inc. · Mar 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F)
K251951 · Guangzhou Red Pine Medical Instrument Co., Ltd. · Dec 2025
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121)
K252468 · Zhejiang Geyi Medical Instrument Co., Ltd. · Dec 2025
Miniature Telescope for Urology (27033AA)
K253411 · Karl Storz SE & CO. KG · Nov 2025
Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
K250917 · Shenzhen Sanping Image Technology Co., Ltd. · Oct 2025
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
K252806 · Shanghai AnQing Medical Instrument Co., Ltd. · Oct 2025

More from Shanghai AnQing Medical...

View all
InnovexView (GC146-17, GC150-20, GC155-23)
K254251 · HIH · Feb 2026
Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.)
K252806 · FGB · Oct 2025
Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
K252598 · FAJ · Sep 2025
Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US)
K251752 · EOQ · Aug 2025
Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US
K243497 · EOQ · May 2025